The indication for use of the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks is to receive, process, display, and transmit medical images.

Device Description

The subject device consists of a computer (system unit, display, keyboard, and mouse) and software. The subject device is a software modification of the predicate device. The modification may be to either existing or newly-installed predicate devices. One of two software modifications may be installed:
1? The network software adds network communication capability and newly permits lossy compression/decompression of approximately 5:1, 12:1, or 20:1. A "transmitter" network HI-C654 is connected directly to an image reader and can transmit images which optionally have undergone lossy compression to a network. A "receiver" network HI-C654 is connected only to the network and can receive images from the network. The transmitter/receiver status is indicated at power-on. Lossily compressed images are so labeled on the CRT display, along with a compression code which indicates the approximate compression rate.
2? The multimodality software a) includes the capabilities of the network software above, and b) adds the ability to receive images from multiformatters
3? The subject device connects either directly to one or two FCR® image readers, or to a proprietary network. The network may have on it FCR® image readers and Fuji multiformatters with image data from other imaging modalities such as CT, MR, DSA, NM, for example.
The device receives images from the FCR® image reader or network and stores, process, and displays the image. Stored images may be transmitted to other devices, such as multiformatters, archiving units, or other CRT image consoles.

AI/ML Overview

The provided document is a 510(k) summary for the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks. However, it does not contain information about specific acceptance criteria or a detailed study designed to prove the device meets those criteria.

The document largely focuses on demonstrating substantial equivalence to a predicate device (K931002) and describes the device's technological characteristics, particularly the addition of networking capabilities and optional lossy compression.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a specific study proving it meets such criteria, as this information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document regarding a "study" of the device, even though it's not a formal clinical performance study in the way implied by the request:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify quantitative acceptance criteria (e.g., minimum diagnostic accuracy, image quality metrics) or report performance against such criteria. The device is primarily a display and transmission system, not a diagnostic algorithm that generates a "performance" metric in the typical sense of accuracy, sensitivity, or specificity.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable in this context: No "test set" of images or patient data is mentioned for evaluating diagnostic performance. The document focuses on regulatory compliance, hardware/software specifications, and safety. The "data" being handled by the device are medical images from various modalities, but there is no study evaluating diagnostic performance using a specific dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable: As there's no diagnostic performance study described, there's no mention of experts establishing ground truth for a test set. The document states that "Images displayed on the CRT image console are interpreted by a physician, providing ample opportunity for competent human intervention," which highlights the human-in-the-loop aspect of its intended use.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, not performed/reported: The document does not describe any MRMC study. This device is a display console, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This device is a display console, not an algorithm providing a standalone diagnostic output. Its function is to "receive, process, display, and transmit medical images" for interpretation by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: No ground truth is established for the device itself, as it is not a diagnostic device in the sense of making a medical judgment.

8. The sample size for the training set

Not Applicable: The device is not described as involving machine learning or AI that would require a "training set" for diagnostic algorithm development.

9. How the ground truth for the training set was established

Not Applicable: As above, no training set or ground truth for such a set is mentioned.

What performance data is mentioned in the document:

The "Performance Data" section ([21 CFR 807.92(b)(1)]) in the document states:

"The IEEE802.3 standard transceiver for Ethernet connection is employed."
"The subject and predicate devices both use standard data communications controls to detect and correct errors."
"The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment."

These points refer to standard compliance and data integrity mechanisms, not diagnostic performance or image quality metrics. The "study" here is essentially compliance with engineering and safety standards, and a demonstration of substantial equivalence to the predicate device regarding its intended use and technological characteristics (handling images, displaying them, and transmitting them). The introduction of "lossy compression" is addressed by labeling the compressed images on the display, acknowledging the potential impact on image quality, and placing the ultimate interpretation responsibility on the physician.

Summary

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SEP 1 2 1997

510(k) Summary [as required by 21 CFR 807.92]

Date Prepared [21 CFR 807.92(a)(1)]

June 13, 1997

Submitter's Information [21 CFR 807.92(a)(1)]

Fuji Medical Systems U.S.A., Inc. Post Office Box 120035 Stamford, Connecticut 06912-0035 Telephone: +1 203 973-2664 +1 203 973-2777 facsimile: Contact: Robert A. Uzenoff

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are:

FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks .
FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display Sys-. tem

Predicate Device [21 CFR 807.92(a)(3)]

FDA classified the predicate FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 with the FDA product code IXK as a regulatory class II medical device "System, Imaging, X-ray, Electrostatic", citing 21 CFR & 892.1630 "Electrostatic X-ray Imaging System" under 510(k) K931002. Under FDA's proposed rules (61 FR 63774 of December 2, 1996) Fuji believes FDA would classify this device as Class II, 21CFR 892.2050 "picture archiving and communications system".

FDA's accession number for the premarket notification for the predicate device is K931002. Fuji received notifications that FDA cleared the marketing of the predicate device in a letter uated June 8, 1993.

Description of the Device [21 CFR 807.92(a)(4)}

1? The network software adds network communication capability and newly permits lossy compression/decompression of approximately 5:1, 12:1, or 20:1. A "transmitter" network HI-C654 is connected directly to an image reader and can transmit images which optionally have undergone lossy compression to a network. A "receiver" network HI-C654 is connected only to the network and can

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receive images from the network. The transmitter/receiver status is indicated at power-on. Lossily compressed images are so labeled on the CRT display, along with a compression code which indicates the approximate compression rate. See page XXX.

2? The multimodality software a) includes the capabilities of the network software above, and b) adds the ability to receive images from multiformatters

3? The subject device connects either directly to one or two FCR® image readers, or to a proprietary network. The network may have on it FCR® image readers and Fuji multiformatters with image data from other imaging modalities such as CT, MR, DSA, NM, for example.

The device receives images from the FCR® image reader or network and stores, process, and displays the image. Stored images may be transmitted to other devices, such as multiformatters, archiving units, or other CRT image consoles.

Intended Use [21 CFR 807.92(a)(5)]

The indication for use of the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks is to receive, process, display, and transmit medical images.

Technological Characteristics [21 CFR 807.92(a)(6)]

The device does not create image data, does not contact the patient, nor does it control any life sustaining devices. Images displayed on the CRT image console are interpreted by a physician, providing ample opportunity for competent human intervention.

The subject device is a software modification of the predicate. No new hardware issues are raised.

The device newly permits (optional) lossy data compression. Three irreversible compression types are available with approximate compression rates of: 5:1, 12:1, and 20:1. A single compression type is set by service personnel for each device and cannot be modified by the user. Adjacent to every lossily compressed image, the soft label "irreversibly compressed" is displayed on the CRT along with an indication of the approximate compression ratio. The effects on image quality of irreversible compression and decompression are discussed in the operation manual.

Data loss may occur because of hardware failure (e.g. hard disk crash) or operator error (e.g. turning off power during hard disk access). However, as the device is not the data source nor image archive, the data can be recovered by requesting a retransmission from the other host modalities (CT, MR, US, NM) or optical disk filing equipment after recovering from a failure. Operation is password protected to prevent unauthorized use. The software does not allow access to the link between image and relevant patient ID information preventing patient image mix-ups.

Performance Data [21 CFR 807.92(b)(1)]

The IEEE802.3 standard transceiver for Ethernet connection is employed. The subject and predicate devices both use standard data communications controls to detect and correct errors.

The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.

Conclusion [21 CFR 807.92(b)(3)]

As is the case with the predicate, the subject device has no patient contact. Nor do the subject device control, monitor, or effect any devices directly connected to or effecting a patient. The images relayed by the subject devices are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

Irreversibly compressed and decompressed images are so labeled along with an indication of the compression type. Standard communications error detection and correction methods are employed. Device

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1 DA 3 10(x) 1 remarket Normeanen
FCR® Fuji Computed Radiography Print Console HI-C654 Multimodality Display System for Networks

failures which might result in a failed transmission may be recovered from by retransmission after correcting the problem. Passwords are required for operation to protect against unauthorized use.

The subject and predicate share the same certification of conformance to the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment. We conclude that the subject devices are as safe and effective as the predicate device.

RA Uzenoff h:\user\tech_grp\doc\510k_654.doc 12/13 97/06/13 13:21

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image.

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a human figure.

SEP 1 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert A. Uzenoff Fuji Medical Systems U.S.A., Inc. 333 Ludlow Street P.O. Box 120035 Stamford, CT 06912-0035

Re: K972256

FCR® Fuji Computed Radiography DMS CRT Image Console 41-C654 Multimodality Display System For Networks Dated: June 13, 1997 Received: June 16, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Uzenoff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Aproval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William Kin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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972256 5 10(k) Number (if known): K

Device Name: Fuji Medical Laser Imager MF Print Server MF-PS667

Indications For Use:

The indication for use of the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks is to receive, process, display, and transmit medical images.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Yhird h. Leymon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).